Charter
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Charter
Purpose
Title XXVI of the Children's Health Act
of 2000, "Screening for Heritable
Disorders," establishes a program
to improve the ability of States to provide
newborn and child screening for heritable
disorders. Title XXVI enacts three sections
of the Public Health Service (PHS) Act:
sections 1109, 1110, and 1111.
Section 1109 of the PHS Act authorizes
the Secretary to award grants to States,
or a political subdivision of a State,
or a consortium of two or more States,
or political subdivisions of States to
enhance, improve or expand the ability
of States and local public health agencies
to provide screening, counseling or health
care services to newborns and children
having or at risk for heritable disorders.
Section 1110 of the PHS Act authorizes
the Secretary to award grants to eligible
entities to provide for the conduct of
demonstration programs to evaluate the
effectiveness of screening, counseling
or health care services in reducing the
morbidity and mortality caused by heritable
disorders in newborns and children.
The Secretary of Health and Human Services
(HHS) is directed under section 1111 of
the PHS Act to establish an Advisory Committee
on Heritable Disorders in Newborns and
Children (Committee). HHS has expanded
the Committee to include genetic diseases
and has renamed the Committee accordingly.
The Committee's purpose is to provide
to the Secretary advice and recommendations
concerning the grants and projects authorized
under section 1109 and technical information
to develop policies and priorities for
this program that will enhance the ability
of the State and local health agencies
to provide for newborn and child screening,
counseling and health care services for
newborns and children having or at risk
for heritable disorders. Specifically,
the Committee shall advise and guide the
Secretary regarding the most appropriate
application of universal newborn screening
tests, technologies, policies, guidelines
and programs for effectively reducing
morbidity and mortality in newborns and
children having or at risk for heritable
disorders.
Authority
Section 1111 of the PHS Act, 42 U.S.C.
300b-10. The Committee is governed by
the provisions of Public Law 92-463, as
amended (5 U.S.C. App. 2), and 41 CFR
Part 102-3, which sets forth standards
for the formation and use of advisory
committees.
Functions
The Advisory Committee on Heritable Disorders
and Genetic Diseases in Newborns and Children
shall review and report regularly on newborn
and childhood screening practices, recommend
improvements in the national newborn and
childhood screening programs, and shall
engage in the following activities:
- Provide advice and recommendations
to the Secretary concerning grants and
projects awarded or funded under Section
1109 of the PHS Act;
- Provide technical information to
the Secretary for the development of
policies and priorities for the administration
of grants under Section 1109 of the
PHS Act; and
- Provide such recommendations, advice
or information as may be necessary to
enhance, expand or improve the ability
of the Secretary to reduce the mortality
or morbidity in newborns and children
from heritable disorders.
Structure
The Committee structure shall not exceed
15 members, including the Chair and the
ex-officio and liaison members. The total
membership of the Committee shall be an
odd number. The Secretary or his designee
shall appoint as ex-officio members to
the Committee, the Administrator of Health
Resources and Services Administration
(HRSA); the Directors of the Centers for
Disease Control and Prevention (CDC),
the National Institutes of Health (NIH),
and the Agency for Healthcare Research
and Quality (AHRQ); or their designees
and representatives of such Federal agencies
as the Secretary determines are necessary
for the Committee to effectively carry
out its functions. Other members and the
Chair shall be selected by the Secretary
or his designee from medical, technical,
public health or scientific professionals
with special expertise in the field of
heritable disorders or in providing screening,
counseling, testing or specialty services
for newborns and children at risk for
heritable disorders and from members of
the public having special expertise about
or concern with heritable disorders. The
Committee shall also include individuals
from relevant medical professional and
public health organizations, as determined
to be necessary by the Secretary. Of the
appointed members, there shall be at least
two liaison members: at least one shall
be a current voting member of the Secretary's
Advisory Committee on Genetics, Health
and Society, and another shall be a current
voting member of the Secretary's Advisory
Committee on Infant Mortality.
Members shall be invited to serve for
overlapping terms of up to 4 years. However,
any member appointed to fill a vacancy
of an unexpired term shall be appointed
for the remainder of such term. Members
may serve after the expiration of their
term until their successors have taken
office. Terms of more than 2 years are
contingent upon the renewal of the Committee
by appropriate action prior to its expiration.
There may also be nonvoting representatives
from organizations such as the American
Academy of Family Physicians; the American
Academy of Pediatrics; the American Association
of Health Plans; the American College
of Obstetricians and Gynecologists; the
American College of Medical Genetics;
the American Academy of Nurse Practitioners;
the Association of Women's Health, Obstetrics
and Neonatal Nurses; the Biotechnology
Industry; the Center for Medicaid-Medicare
Services; the Food and Drug Administration;
and such other nonvoting representatives
as it is deemed necessary to effectively
carry out the functions of the committee.
Coordination, management, and operational
services shall be provided by the Office
of the Associate Administrator, Maternal
and Child Health Bureau, HRSA, with direction
and guidance from the Assistant Secretary
for Health. HRSA will select the Designated
Federal Official to attend each Committee
meeting and ensure that all advisory committee
procedures are within applicable statutory,
regulatory, and HHS General Administration
Manual directives. Agenda development
will be coordinated by HRSA with the ex-officio
members from CDC, NIH, and AHRQ and the
Chair of the Committee. The Committee
shall report to the Secretary through
the Office of the Assistant Secretary
for Health.
A quorum for the conduct of business
by the full Committee shall be a simple
majority of the appointed voting members.
Liaison members and representatives are
nonvoting members.
As necessary, standing and ad hoc subcommittees
composed of members of the parent committee
may be established to perform specific
functions within the Committee's jurisdiction.
The Department Committee Management Officer
will be notified upon establishment of
each standing subcommittee and will be
provided information on its name, membership,
function, and estimated frequency of meetings.
The Committee shall be able to call upon
special consultants, assemble ad hoc working
groups, and convene hearings as necessary
to assist in the work of the Committee.
Meetings
Meetings shall be held at least twice
a year or more often as deemed necessary
by the Chair in consultation with the
Designated Federal Official. The Designated
Federal Official or his/her designee shall
be present at all meetings of the full
committee and may elect to participate
on an ad hoc basis in workgroup and subcommittee
meetings or hearings.
Meetings shall be open to the public
except as determined otherwise by the
Secretary or other official to whom the
authority has been delegated. Notice of
all meetings shall be given to the public.
Meetings shall be conducted and records
of the proceedings kept, as required by
applicable law, regulation and the HHS
General Administration Manual.
Compensation
Members who are not Federal employees
shall be paid at a rate of $200 per day
for each day they are engaged in the performance
of their duties as members of the Committee.
Members shall receive per diem and travel
expenses as authorized by Section 5 U.S.C.
5703 for persons employed intermittently
in Government service. Members who are
officers or employees of the United States
Government shall not receive compensation
for service on the Committee.
Annual Cost Estimate
Estimated annual cost for operating the
Committee, including compensation and
travel expenses for members but excluding
staff support, is S138,526. Estimated
annual person-years of staff support required
are .83 at an estimated annual cost of
$147,973.
Reports
In the event a portion of a meeting is
closed to the public, as determined by
the Secretary of HHS, in accordance with
the Government in the Sunshine Act (5
U.S.C. 552b(c)) and the Federal Advisory
Committee Act, an annual report shall
be prepared which shall contain, at a
minimum, a list of the members and their
business addresses, the Committee's function,
dates and places of meetings, and a summary
of committee activities and recommendations
made during the fiscal year. A copy of
the report shall be provided to the Department
Committee Management Officer.
Termination Date
Unless renewed by appropriate action prior
to its expiration, the Advisory Committee
on Heritable Disorders and Genetic Diseases
in Newborns and Children will terminate
2 years from the date this charter is
filed.
Approved: January 9, 2007
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